So, your new product is ready for the next step – commercial manufacturing production. You have decided not to invest in new equipment or building a new manufacturing line. You’re now looking to partner up with a contract manufacturing organization (CMO) for your commercial needs. What should you expect from your CMO/CDMO partner? Better quality, fewer product failures, and stronger expertise are some skills that probably come up immediately in your mind.
Working with your CMO partner to invest in new equipment or build a whole new line for Oral Solid Dosage (OSD), semi-solid, or liquid manufacturing and packaging, you will need to collaborate with your contract manufacturing partner to target solutions to achieve outstanding results. Before producing that first batch, the equipment or the whole line needs to be qualified under cGMP requirements and that includes purchasing, construction, installation qualification, operational qualification, performance qualification, and process performance qualification (IQ/OQ/PQ/PPQ). These all require engineering expertise which a good contract manufacturing partner will provide because they have a strong background in manufacturing and quality systems.
An Engineering Batch can also be called an engineering trial run, engineering lot or practice runs. It’s a non-cGMP run that is used for developing specifications, demonstrating manufacturing process steps, or identifying and resolving any potential issues before the formal cGMP documentation and activities. It may have certain restrictions according to the facility’s SOPs or policy. An engineering trial run is mainly to ensure that the equipment can be operated in good condition according to the facility’s/utilities' conditions, limitations, and capacity.
Challenges will inevitably be encountered before or during manufacturing. However, to minimize the cost, time, and smooth the process before commercial production, an engineering batch run can help avoid many predictable and unpredictable issues.
After installation of new equipment or installation of a new manufacturing line, Site Acceptance Testing (SAT), commissioning, and/or qualification are required to be applied under good manufacturing procedure (GMP). During these activities, an engineering trial can be involved in certain testing and training. An engineering batch can also be applied for improvement purposes after the product has been launched.
The scale of an engineering trial could vary according to the purpose and complexity of the trial; which is from testing an equipment function to a study batch runs as part of technology transfer projects.
There are many benefits of doing an engineering run, such as:
As you can see, there are many benefits of conducting engineering trials. It is best to speak with your CMO partner early on to make sure you are both aligned and have well-defined tech transfer plans. The right contract manufacturing partner will have many solutions and plenty of experience in conducting these.